Consumer medicine information

1 Medicine name

Molybdenum [⁹⁹Mo]/Technetium [⁹⁹mTc] Sterile Generator

For Production of Sodium Pertechnetate [⁹⁹mTc] Injection Multidose Vial.

2 Special advisory

Radiopharmaceuticals should be used only by physicians who are qualified by specific training in the safe use and handling of radionuclides produced by a nuclear reactor or particle accelerator, and whose experience and training have been approved by the appropriate government agency authorised to license the use of radionuclides.

Care should be taken to minimise radiation exposure to patients, consistent with proper patient management. As with other radioactive drugs, sodium pertechnetate [⁹⁹mTc] must be handled with care and appropriate safety measures should be used to minimise radiation exposure to clinical personnel.

3 Why am I being given the GENTECH (Sodium Pertechnetate [⁹⁹mTc] Injection)?

You are being given the Sodium Pertechnetate [⁹⁹mTc] Injection for imaging of your body organs.

When injected, the radioactive pertechnetate will temporarily collect in certain organ areas of your body. Using special cameras your doctor will then detect this radioactivity to produce an image (scan) of the concerned organ. These images can provide your doctor valuable information about the structure and function of your body organ.

Sodium Pertechnetate (⁹⁹mTc) injection is used for a variety of diagnostic procedures, such as brain and thyroid imaging.

Sodium Pertechnetate (⁹⁹mTc) injection can also be mixed with other reagents to help your doctor see images of your liver, lung, bone and kidney.

Ask your nuclear medicine specialist why you have been referred for a Sodium Pertechnetate (⁹⁹mTc) scan.

4 What should I know before I use GENTECH (Sodium Pertechnetate [⁹⁹mTc]) Injection?

All medicines and diagnostic agents have risks and benefits associated with their usage. Your nuclear medicine specialist has weighed the risks of you being treated with Sodium Pertechnetate (⁹⁹mTc) against the benefits of the procedure.

Before you are given Sodium Pertechnetate (⁹⁹mTc) injection, it is important to tell your nuclear medicine specialist or technologist if:

(i) You have had a scan in the previous 6 weeks or have kidney problems or any digestive obstruction.

(ii) You are, or may be pregnant:
Your specialist will discuss your options with you.

(iii) You are breast-feeding:
Depending upon your test, you should discontinue breast-feeding from 6 to 36 hours after your scan whilst the radioactivity is being cleared naturally from your body. You will be advised of the time to recommence breast-feeding.

(iv) If you have any allergies, or have previously experienced allergic reactions after administration of sodium pertechnetate (⁹⁹mTc) solution.

(v) If you have any form of kidney disease.

5 What if I am taking other medicines?

It is very important that you tell your doctors if you are taking any other medicines, including those you buy without a prescription from your pharmacy, supermarket or health food shop (e.g. vitamins, cough medicines and nasal decongestants). If your medication may affect the diagnosis due to possible interactions, your nuclear medicine specialist will advise you what to do.

6 How do I use GENTECH (Sodium Pertechnetate [⁹⁹mTc] Injection)?

It is given as an injection into a vein in your arm. For some tests it may be necessary to take a sample of your blood prior to your injection.

What is the test procedure?

After injecting Sodium Pertechnetate (⁹⁹mTc), a body scan will be made using a special camera. It is painless and may take from 5 to 40 minutes depending on your particular test. Multiple views may be taken, often from different angles. Having more views taken will not increase your radiation dose.

7 What should I know while using GENTECH (Sodium Pertechnetate [⁹⁹mTc] Injection)?

(a) Before you are given it
Drink plenty of water before the start of the examination in order to urinate as often as possible during the first hours after the study.

(b) Preparation
Usually no preparation is required for these tests. Specific instructions are given when required. Your doctor will decide on the quantity of sodium pertechnetate (⁹⁹mTc) solution to be injected.

(c) After your injection and scan
Avoid any close contact with young children and pregnant women for the 12 hours following the injection. You may be encouraged to drink fluids and pass urine frequently for about 6 hours following your scan; this is to help flush the Sodium Pertechnetate (⁹⁹mTc) from your body.

YOUR DOCTOR WILL TELL YOU IF YOU NEED TO TAKE ANY SPECIAL PRECAUTIONS AFTER RECEIVING THIS INJECTION.

8 Are there any side effects?

Like all medicines, this medicine can cause side effects, although not everybody experiences these. The following side effects could be observed:

Hypersensitivity, with symptoms such:

• Urticaria - also known as hives, could be in the form of itchy rash on the skin.
• Pruritus - an unpleasant sensation that provokes the desire to scratch.

Cardiovascular, with symptoms such:

• Arrhythmia - rapid heartbeat, slow heartbeat.
• Vasodilation - widening of blood vessels.

Body as a whole, with symptoms such as:

• Facial oedema - Face swelling is the enlargement or distention of the face due to fluid build-up or inflammation in the facial tissues.
• Coma - a state of prolonged unconsciousness.

Tell your doctor or the nuclear medicine technologist if you feel unwell after your injection.

9 Sponsor

ANSTO
New Illawarra Rd,
Lucas Heights
NSW 2234, Australia

Mailing address:
ANSTO, Locked Bag 2001
Kirrawee DC
NSW 2232, Australia

Telephone: 1800 251 572
E-mail: health@ansto.gov.au
Website: www.ansto.gov.au

ARTG number: AUST R 72820 and 75859

10 Date of revision

July 2021.

Published by MIMS October 2021

1 Name of Medicine

Molybdenum [⁹⁹Mo]/technetium [^99mTc] sterile generator.
For production of sodium pertechnetate [^99mTc] injection multidose vial.

2 Qualitative and Quantitative Composition

Description. ANSTO's Gentech Generator provides a means of obtaining a sterile, isotonic, additive and pyrogen free solution of sodium pertechnetate [^99mTc] injection (fission) BP. The generator contains fission-product molybdenum-99 [⁹⁹Mo] from which ^99mTc is separated by elution into evacuated vials.
The generator consists of a sealed glass vessel containing aluminium oxide. The ⁹⁹Mo is firmly bound to the alumina and as a result, the eluted ^99mTc contains negligible amounts of ⁹⁹Mo. Over the life of the generator, an elution will provide a yield of approximately 90% of the theoretical amount of ^99mTc available from the ⁹⁹Mo contained within the generator vessel.
Active ingredient. Each vial of eluted solution contains active ^99mTc in 0.9% sodium chloride solution for injections BP.
Quantity: 10 to 370 GBq at calibration.
Physical characteristics. Technetium-99m [^99mTc], with a physical half-life of 6.02 hours, decays by isometric transition to ⁹⁹Tc. Photons associated with this transition which are useful for detection and imaging studies are listed in Table 1.
https://stagingapi.mims.com/au/public/v2/images/fulltablegif/GENTEC01.gif External radiation. The specific gamma ray constant for ^99mTc is 0.19 mGy per MBq^-h-1 at 1 cm. The first half value thickness of lead for ^99mTc is 0.2 mm. Attenuation by lead is given in Table 2.
https://stagingapi.mims.com/au/public/v2/images/fulltablegif/GENTEC02.gif Elution behaviour. Molybdenum-99, with a half-life of 2.75 days, decays to ^99mTc. The physical decay characteristics of ⁹⁹Mo are such that 87.5% of its disintegrations form ^99mTc. The decay of ⁹⁹Mo to ^99mTc occurs until a transient equilibrium is reached when the ^99mTc decay rate equals the rate of its generation, which in turn is proportional to the decay rate of ⁹⁹Mo, a period of approximately 23 hours. Hence, the activity of ^99mTc available for elution from the generator will depend upon the time interval from the last elution. Table 3 shows the ^99mTc activity for a given growth period following complete elution, relative to the ⁹⁹Mo activity contained in the generator at the end of the growth period. See Tables 4 and 5.
https://stagingapi.mims.com/au/public/v2/images/fulltablegif/GENTEC03.gif https://stagingapi.mims.com/au/public/v2/images/fulltablegif/GENTEC04.gif https://stagingapi.mims.com/au/public/v2/images/fulltablegif/GENTEC05.gif Excipient(s) with known effect. Each mL of sodium pertechnetate (^99mTc) solution contains 3.5 mg of sodium.
For full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Clear and colourless sodium pertechnetate [^99mTc] solution for I.V. injection eluted from the radionuclide generator.

4 Clinical Particulars

4.9 Overdose

In the event of an administration of a radiation overdose with sodium pertechnetate [^99mTc], increasing the elimination of the radionuclide from the body should reduce the absorbed dose. Measures to reduce possible harmful effects include frequent voiding of urine and promotion of diuresis and faecal excretion. Very little treatment can be undertaken in the event of an overdose of [^99mTc] labelled red blood cells since elimination is dependent on the normal haemolytic process.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. No data available.
Carcinogenicity. No data available.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSSOPERT.gif CAS number. 23288-60-0.

7 Medicine Schedule (Poisons Standard)

Unscheduled.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/GENTECST.gif